Last reviewed 2026-05-13 · How we verify

Doxorubicin Hydrochloride (doxorubicin)

Doxorubicin Hydrochloride (generic name: doxorubicin) is a Anthracycline Topoisomerase Inhibitor drug developed by Pfizer. It is currently FDA-approved (first approved 1974) for Acute lymphoid leukemia, Acute myeloid leukemia, disease, Advanced ovarian cancer.

Doxorubicin works by intercalating DNA strands and inhibiting topoisomerase II, an enzyme essential for DNA replication and cell division.

Doxorubicin Hydrochloride, originally developed by Baxter Holding B.V. and currently owned by Pfizer, is a small molecule anthracycline topoisomerase inhibitor targeting Aurora kinase A. It was FDA-approved in 1974 for various cancer indications, including acute lymphoid and myeloid leukemia, ovarian cancer, and breast cancer. As an off-patent medication, doxorubicin is available from multiple generic manufacturers. Key safety considerations include its potential for cardiotoxicity and myelosuppression. Its bioavailability is relatively low at 5%, with a half-life of 32 hours.

At a glance

Mechanism of action

The cytotoxic effect of doxorubicin hydrochloride on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of doxorubicin with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of doxorubicin hydrochloride cytocidal activity.

Approved indications

• Acute lymphoid leukemia
• Acute myeloid leukemia, disease
• Advanced ovarian cancer
• Burkitt's lymphoma
• Carcinoma of breast
• Carcinoma of female breast
• Diffuse non-Hodgkin's lymphoma, large cell
• Follicular non-Hodgkin's lymphoma
• Hodgkin's disease
• Invasive Bladder Malignancy
• Kaposi's sarcoma
• Kaposi's sarcoma associated with AIDS
• Malignant tumor of lung
• Malignant tumor of ovary
• Malignant tumor of thyroid gland
• Metastatic Breast Carcinoma
• Metastatic Gastric Cancer
• Multiple myeloma
• Nephroblastoma
• Neuroblastoma

Boxed warnings

• WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION • Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 1%–20% for cumulative doses ranging from 300 mg/m 2 to 500 mg/m 2 when doxorubicin hydrochloride is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with doxorubicin hydrochloride [see Warnings and Precautions (5.1) ] . • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin hydrochloride [see Warnings and Precautions (5.2) ] . • Extravasation and Tissue Necrosis: Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area [see Warnings and Precautions (5.3) ] . • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4) ] . WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning. • Cardiomyopathy: Myocardial damage can occur with doxorubicin hydrochloride with incidences from 1%–20% for cumulative doses from 300 mg/m 2 to 500 mg/m 2 when doxorubicin hydrochloride is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with doxorubicin hydrochloride. ( 5.1 ) • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin hydrochloride. ( 5.2 ) • Extravasation and Tissue Necrosis: Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision and skin grafting. Immediately terminate the drug, and apply ice to the affected area. ( 5.3 ) • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur. ( 5.4 )

Common side effects

• Nausea and vomiting
• Vomiting >12 hours
• Alopecia
• Partial
• Nausea only
• Weight loss to 10%
• Weight gain to 10%
• Thrombocytopenia Grade (25,000 to 49,999 /mm 3)
• Leukopenia Grade (1,000 to 1,999 /mm 3)
• Thrombocytopenia Grade (<25,000 /mm 3)
• Leukopenia Grade (<1000/mm 3)
• Shock, sepsis

Drug interactions

• streptozocin

Key clinical trials

• Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
• Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
• Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (PHASE3)
• Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
• Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PHASE2,PHASE3)
• A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
• A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
• Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Doxorubicin Hydrochloride CI brief — competitive landscape report
• Doxorubicin Hydrochloride updates RSS · CI watch RSS
• Pfizer portfolio CI

Frequently asked questions about Doxorubicin Hydrochloride

Related

• Drug class: All Anthracycline Topoisomerase Inhibitor drugs
• Target: All drugs targeting Aurora kinase A
• Manufacturer: Pfizer — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Acute lymphoid leukemia
• Indication: Drugs for Acute myeloid leukemia, disease
• Indication: Drugs for Advanced ovarian cancer

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing